It is known in the art to provide an excision of a segment of diseased colon or intestine as a result, for example, of a perforation, bleeding, inflammation, or tumor and to provide an anastomosis of the cut end portions. This can be conducted by opening the peritoneal cavity or laparoscopically. However, there are two significant problems associated with these procedures.
The integrity of the anastomosis must be sound so that there is no risk of the anastomosis rupturing or leaking into the peritoneal cavity, causing contamination of the clean interior of the peritoneal cavity. Further, opening the bowel and exposing the clean peritoneal cavity to contamination increases the risk of postoperative complications. There have been a number of improvements in the anastomosis procedure over the past decade.
Reference is made to U.S. Pat. No. 5,197,648 to Gingold on Mar. 30, 1993 entitled “Surgical stapling apparatus.” There is disclosed an improved circular anastomosis surgical stapling instrument for joining hollow tubular organs. The instrument includes a staple-carrying assembly at its distal end, a centered longitudinally extensible and retractable main shaft centered in the body, and an anvil opposed to the staple-carrying assembly. In a preferred form the end of the main shaft is provided with a plurality of radially extendable arms positioned to overlie the main shaft having spring hinges biasing them radially outwardly away from the main shaft. The instrument also has a second shaft segment in the hollow of the main shaft, which has a conical pointed unit at its distal end.
Reference is also made to U.S. Pat. No. 5,312,024 to Grant, et al. on May 17, 1994 entitled “Surgical anastomosis stapling instrument with flexible support shaft and anvil adjusting mechanism.” There is disclosed a stapling instrument for circular anastomosis stapling. The instrument includes a stapling head flexibly mounted by a support shaft to an actuator handle. The support shaft is radially flexible and suitable for insertion into a patient. The flexible support shaft includes a dual coil structure, to be self-supporting in any curved configuration and to resist deflection upon insertion into the patient during actuation of the stapler. The stapling head includes a driver assembly, which is operable to separate staple forming and tissue cutting actions. The actuator handle includes a staple actuator and a cam follower assembly, to facilitate the operation of the instrument by a surgeon. The actuator handle includes a thumb wheel for opening and closing the anvil and an adjusting knob for adjusting the anvil gap. There is also provided a control lever for pivoting the stapling head relative to the flexible support shaft.
Reference is further made to U.S. Pat. No. 5,344,059 to Green, et al. on Sep. 6, 1994 entitled “Surgical apparatus and anvil delivery system therefore.” There is disclosed a detachable anvil assembly for use with a circular anastomosis apparatus for tubular organs. This includes an anvil rod with an anvil head mounted on the distal end thereof. The distal end portion is adapted to pivot by about ninety degrees relative to the axis of the rod. A delivery system facilitates delivery of the anvil assembly to the operative site. The pivoting feature of the distal end reduces the transverse profile of the assembly, consequently facilitating introduction and advancement of the anvil assembly into the organ.
Referring, additionally, to U.S. Pat. No. 5,411,508 to Bessler, et al. on May 2, 1995 entitled “Gastrointestinal approximating and tissue attaching device,” there is disclosed a steerable intestinal endoscopic stapler. The stapler comprises a circular anvil with a circular stapling anvil surface and a trimming surface, disposed radially inwardly of the stapling surface. A circular stapler drives staples in an array corresponding to the anvil surface and a circular cutting blade operates corresponding to the cutting block. A scope in the hand piece optically connected to a lens in the head assembly is provided for viewing beyond the head assembly. A steering arrangement is provided for steering the head assembly. An activator at the hand piece is for driving staples toward the anvil and for driving the cutting blade toward the cutting block. Tubular tissue ends are joined by staples and excess tissue is trimmed off with the blade.
In addition, reference is made to U.S. Pat. No. 5,639,008 to Gallagher, et al. on Jun. 17, 1997 entitled “Anvil for circular stapler.” There is disclosed an anvil for a fastening instrument. The anvil pivots relative to a shaft to facilitate movement of the anvil and instrument. The anvil also has an improved surface for severing tissue and a sloped surface for guiding a knife during use.
In order to avoid opening the bowel and exposing the clean peritoneal cavity, intussusception of the colon or intestine enables the excision to be conducted extra corporeally, that is, outside the body cavity, preventing contamination of the body cavity. There has been a development recently whereby the intussusception, anastomosis and resection of the intussuscepted segment is facilitated.
Reference is made to U.S. Pat. No. 6,117,148 to Ravo, et al. on Sep. 12, 2000 entitled “Intraluminal anastomotic device.” There is disclosed a bowel intussusception, anastomosis and severing mechanism for the resected bowel. The device enables these procedures, without exposing the contaminated intraluminal content to the clean abdominal or thoracic cavities. By tying the bowel to a post, which is withdrawn, intussusception is accomplished. Thereafter, anastomosis by stapling and finally intraluminal resection is carried out.
Each of the foregoing inventions utilizes stapling for causing anastomosis of the portions of bowel or intestine to be joined. It would be advantageous to utilize a procedure and apparatus that did not rely on applying a plurality of staples or other connecting devices, which, of necessity, remain in the bowel and which, despite the utmost care by the surgeon, may leak or rupture.
It is known in the art to provide a surgical fastening clip, which applies a clamping force to a site, such as a blood vessel, thereby reducing its cross-sectional area. It is also known to provide a surgical fastening clip formed of a shape memory alloy which deforms to a closed configuration when heated, such that the clamping force applied thereby is increased as it is heated. For example, U.S. Pat. No. 5,171,252 discloses a surgical fastening clip formed of a shape memory alloy; the device disclosed therein includes separate legs which close tightly around a site. Such a device is limited in its uses, such as for clamping blood vessels, and is not suitable for joining portions of the gastrointestinal tract.
EP 0,326,757 to Fujitsuka Tatsuo Aug. 9, 1999 entitled “Apparatus for anastomosing digestive tract,” discloses a device for anastomosing a digestive tract, which includes a plurality of U-shaped retaining clips disposed around a soluble support tube. The tube is positioned inside portions of the digestive tract to be joined, and includes an outer groove around which are disposed the U-shaped retaining clips. The retaining clips are made of a shape memory alloy such that the open ends thereof close at a predetermined temperature, thus joining ends of the digestive tract. Once the ends of the digestive tract have been joined, the tube is dissolved. Such a device is disadvantageous in that its use requires that a plurality of clips to be properly positioned simultaneously. Also, there is no assurance that the resulting junction will be smooth, due to the plurality of sites of the digestive tract joined by the plurality of clips.
SU 1,186,199 to Makarov et al Oct. 23, 1985 entitled “Method Of Making Anastomoses,” discloses a memory alloy clip consisting of two parallel coils to be used for joining portions of a hollow organ, such as an organ of the gastrointestinal tract. The portions of the organ to be joined are aligned, and each of the plastic coils is introduced through a puncture formed in the wall of one of the portions. The coils are positioned such that, when heated, they compress the aligned walls therebetween, thus maintaining the portions of the walls held within the loops of the coils adjacent each other. Thereafter, incisions are made through the portions of the walls held within the loops of the coils, such that a passageway is created between the two organ portions. The punctures in the organ walls must then be surgically sewn closed with interrupted surgical sutures.
A major disadvantage of known memory alloy clips is that they permit compression of only approximately 80-85% of the junction perimeter, thus requiring additional manual sutures, which reduce the seal of the junction during the healing period and its elasticity during the post-operative period. Also, this additional suturing is problematic inasmuch as it has to carried out across a joint which includes a portion of the clip, thereby rendering difficult the sealing and anastomosis of the organ portions. Furthermore, once in place, clips according to the prior art require further surgery to be performed, namely, incisions through tissue so as to create a passageway between the two organ portions which have been joined by the clip.
Referring now to U.S. Pat. No. 6,402,765 to Monassezitch et al. on Jun. 11, 2002 for “Surgical Clip”, there is recited concerning a surgical clip and method for anastomosing a gastrointestinal tract. The clip is formed at least partly of a shape memory alloy, the clip including: a first length of a wire defining a closed geometrical shape having a central opening; a second length of a wire defining a closed geometrical shape similar in configuration and magnitude to that of the first length of wire, wherein, when placed in side-by-side registration, the first and second lengths of wire fully overlap; an intermediate portion located between the first length of wire and the second length of wire, the intermediate portion formed of a shape memory alloy; a cutting element associated with the first length of wire; a counter element associated with the second length of wire and arranged for cutting engagement with the cutting element; wherein when at a first temperature or higher, the first and second lengths of wire are positioned in a side-by-side closed position and the shape memory alloy is in an elastic state, and further, when at a second temperature or lower, below the first temperature, the shape memory alloy is in a plastic state, thereby enabling the first and second lengths of wire to be moved into and to retain a spaced apart position, and upon heating of the clip to a temperature at least equal to the first temperature, the first and second lengths of wire return to the side-by-side closed position, thereby to apply a compressive force to tissue located therebetween.
Referring further to U.S. application Ser. No. 10/158,673 filed on May 30, 2002, for “Surgical Clip Applicator Device”, which is a co-pending continuation-in-part of U.S. Pat. No. 6,402,765 referred to hereinabove, there is disclosed an anastomosis clip applicator device for applying a surgical clip. The surgical clip is formed at least partly of a shape memory alloy, to press together adjacent wall portions of adjacent hollow organ portions so as to effect anastomosis therebetween. The applicator device includes: gripping apparatus for gripping a surgical clip, a release mechanism, associated with the gripping apparatus, and tissue cutting apparatus, operatively associated with the gripping apparatus. There is also apparatus for activating the gripping apparatus, the release mechanism and the cutting apparatus, so as to introduce and apply the surgical clip into adjacent hollow organ portions, such that the surgical clip compresses together the adjacent walls of the hollow organ portions, and thereafter causes the cutting apparatus to perforate the adjacent pressed together organ walls to provide patency through the joined portions of the hollow organ.
The surgical clip and the anastomosis clip applicator device, recited respectively in U.S. Pat. No. 6,402,765 and U.S. application Ser. No. 10/158,673 referred to herein above, relate to a memory alloy clip for insertion through apertures formed in the side-walls of a pair of adjacent hollow organ portions utilizing an anastomosis clip applicator device. Access to the hollow organ is generally extra-tubular, that is, achieved by means of an open surgery or a laparoscopic procedure during which access to the organ parts results in the risk of exposure of the peritoneal cavity to contamination from the excised organs. Furthermore, the nature of the anastomosis provides a join of the organ portions through the adjacent side-walls; whereas a join formed in the in-line excised ends is generally preferred, specifically avoiding the possibility of a resistance to or reduction in the flow through the anastomosed adjacent organ portions.
There is thus a need for a surgical apparatus which facilitates compression of substantially the entire perimeter of the junction between the organ portions being joined, which would obviate the need for additional manual sutures and which ensures the smooth seal of the junction during the healing period and its elasticity during the post-operative period. Additionally, there is a need for a surgical apparatus, which, once in place, would enable a clear, straight-through passageway to be created between the two organ portions, which have been joined together, without requiring further surgery to be performed on the organ.